Efficacy of Intralesional Triamcinolone Injection in the Treatment of Vitiligo

Vitiligo Clinical Trial

Official title:

Efficacy of Intralesional Triamcinolone Injection in the Treatment of Vitiligo

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03365141
• Other study ID #: VC17MESI0190
• Status: Recruiting
• Phase: N/A
• First received: November 30, 2017
• Last updated: December 5, 2017
• Start date: November 14, 2017
• Est. completion date: September 15, 2018

Study information

• Verified date: December 2017
• Source: The Catholic University of Korea
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A randomized split-body pilot study was planned to confirm efficacy of intralesiona triamcinolone injection in patients with vitiligo

Description:

Intralesional corticosteroid injections have been a long-standing treatment for refractory vitiligo, with some patients showing significant improvement without surgical intervention.

The investigators will perform a randomized split-body pilot trial to test the exact efficacy of intralesional triamcinolone injections. The paired symmetric vitiliginous lesions will be randomized to either control or injection groups. All lesions will be treated with narrowband UV-B phototerapy or excimer laser weekly and twice daily application of topical tacrolimus ointment for a total of 12-week period. Intralesional injections of 0.4mg/cc triamcinolone once a week are given to the experimental group. The degree of repigmentation will be assessed as % from baseline.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: September 15, 2018
• Est. primary completion date: September 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

1. Age : 19 or older

2. A patient who voluntarily agreed to participate in the study by listening to the explanation of the purpose and method of the study

3. A patient who has bilateral two or more vitiligo lesions with similar degree of progression in the face or trunk

4. A patient who has no further response to excimer laser or short wavelength ultraviolet B therapy, which is a conventional treatment for vitiligo

Exclusion Criteria:

1. Patients under the age of 19

2. Patients with enlarged or spreading lesions of vitiligo

3. Patients who do not want to do so or who refuse to write a consent form

4. Patients who are inadequate for triamcinolone acetonide administration (pregnant women, infectious and systemic fungal infections without effective antimicrobial agents, immunosuppression, hypersensitivity reactions to and concomitant use of triamcinolone or its components, spontaneous thrombocytopenia, purpura, herpes simplex, shingles, chicken pox patients)

5. Others those who are deemed unsuitable for the examination at the discretion of the examiner

Related Conditions & MeSH terms

• Corticosteroid
• Intralesional Injection
• Treatment
• Vitiligo

Intervention

Drug:
• Triamcinolone acetonide 0.4mg/cc
Intralesional injection of dilute triamcinolone acetonide with 2% lidocaine (400mg/20 mL) would be performed to reduce pain when injecting the drug. Once weekly, for a total of 12 weeks

Device:
• Phototherapy (NBUVB or excimer laser)
NBUVB or excimer laser treatment weekly

Drug:
• Topical tacrolimus
Application of topical tacrolimus ointment twice a day

Locations

Country	Name	City	State
Korea, Republic of	St. Vincent's Hospital	Suwon	Gyonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
The Catholic University of Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The repigmentation rate (change from baseline) of the vitiliginous patch	The degree of repigmentation will be assessed as % from baseline by using a computer program.	Baseline and 12 weeks
Secondary	The adverse effects		every weeks up to 13 weeks